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Trial record 2 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02342587
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date February 17, 2017
Actual Study Start Date  ICMJE December 3, 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
overall response rate [ Time Frame: 4 weeks after treatment of lapatinib ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02342587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer
Official Title  ICMJE Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer: A Phase II Single Arm Prospective Study
Brief Summary

Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.

Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.

Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2-positive Refractory Advanced Cancer
Intervention  ICMJE Drug: Lapatinib
Patients will be treated with oral lapatinib 1250mg once daily for 21 days.
Study Arms  ICMJE Experimental: single arm
Patients will be treated with oral lapatinib 1250mg once daily for 21 days.
Intervention: Drug: Lapatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2015)
25
Actual Study Completion Date  ICMJE August 21, 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 19
  • Written informed consent
  • ECOG 0-2,
  • Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  • The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  • Adequate organ function

Exclusion Criteria:

  • Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  • Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  • Prolonged QT interval in ECG (QTc >450 msec)
  • Pregnant, lactating women
  • Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  • Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342587
Other Study ID Numbers  ICMJE 2014-10-028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeeyun Lee, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP